FDA.reportPublic FDA data

General Instrument

Primary DI
00841132128473
Brand
General Instrument
Company
ORTHOPEDIATRICS CORP.
Model
01-1500-9018
Catalog number
01-1500-9018
Device description
Extraction Adaptor
Published
2016-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWBEXTRACTOR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841132128473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841132128473008411321284738411321284730841132128473

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(574)268-6379Rbremer@orthopediatrics.com

Regulatory Flags#

DUNS number
796416191
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
008405368002063P Hip System01-3002-102501-3002-10252026-06-12
008405368002133P Hip System01-3002-202501-3002-20252026-06-12
008405368002203P Hip System01-3002-302501-3002-30252026-06-12
00840536822864Response Spine01-1600-001701-1600-00172026-08-21
00840536822871Response Spine01-1300-011201-1300-01122026-08-21
00840536822888Response Spine01-1300-011301-1300-01132026-08-21
00840536822895Response Spine01-1300-611501-1300-61152026-08-21
00840536822901Response Spine01-1300-611601-1300-61162026-08-21
00840536824707Response Spine01-1600-607301-1600-60732026-08-21
00840536824974PedFlex Flexible Nailing System00-1001-1015-S00-1001-1015-S2026-08-14
00840536824981PedFlex Flexible Nailing System00-1001-1020-S00-1001-1020-S2026-08-14
00840536824998PedFlex Flexible Nailing System00-1001-1025-S00-1001-1025-S2026-08-14
00840536825001PedFlex Flexible Nailing System00-1001-1030-S00-1001-1030-S2026-08-14
00840536825018PedFlex Flexible Nailing System00-1001-1035-S00-1001-1035-S2026-08-14
00840536825025PedFlex Flexible Nailing System00-1001-1040-S00-1001-1040-S2026-08-14
00840536825032PedFlex Flexible Nailing System00-1001-1115-S00-1001-1115-S2026-08-14
00840536825049PedFlex Flexible Nailing System00-1001-1120-S00-1001-1120-S2026-08-14
00840536825056PedFlex Flexible Nailing System00-1001-1125-S00-1001-1125-S2026-08-14
00840536825063PedFlex Flexible Nailing System00-1001-1130-S00-1001-1130-S2026-08-14
00840536825070PedFlex Flexible Nailing System00-1001-1135-S00-1001-1135-S2026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810017915804SABER-XA, Height ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915811SABER-XA, Lordosis ExpanderELEVATION SPINE, INC.HWB2026-08-14
00810017915958Slap HammerELEVATION SPINE, INC.HWB2026-08-14
00810017915965Slap Hammer AdaptorELEVATION SPINE, INC.HWB2026-08-14
03701089527965AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089527972AMPLITUDEAMPLITUDE SASHWB2026-07-29
03701089531276AMPLITUDEAMPLITUDE SASHWB2026-07-29
00889024711495Z1 ExtractorZimmer, Inc.HWB2026-07-20
08800068946966BENCOXCorentec Co., LtdHWB2026-07-01
08800068946973BENCOXCorentec Co., LtdHWB2026-07-01
08800068963666BENCOXCorentec Co., LtdHWB2026-07-01
08806373897344BENCOXCorentec Co., LtdHWB2026-07-01
08806373897351BENCOXCorentec Co., LtdHWB2026-07-01
08806373897368BENCOXCorentec Co., LtdHWB2026-07-01
08806373897375BENCOXCorentec Co., LtdHWB2026-07-01
08806373897382BENCOXCorentec Co., LtdHWB2026-07-01
10603295543695ATTUNEDEPUY (IRELAND)HWB2025-10-31
00810135963411ImpactNVision Biomedical Technologies, Inc.HWB2025-09-24
00840314269737gSourceGSOURCE LLCHWB2025-05-05
00885556820964General InstrumentsSmith & Nephew, Inc.HWB2023-10-27
00818069011031TecometTECOMET INC.HWB2023-08-10
00818069011048TecometTECOMET INC.HWB2023-08-10
00818069011055TecometTECOMET INC.HWB2023-08-10
00818069011062TecometTECOMET INC.HWB2023-08-10
00818069011079TecometTECOMET INC.HWB2023-08-10
00818069011086TecometTECOMET INC.HWB2023-08-10
00818069011093TecometTECOMET INC.HWB2023-08-10
00818069011109TecometTECOMET INC.HWB2023-08-10
00818069011116TecometTECOMET INC.HWB2023-08-10